Simeprevir Data from COSMOS Study in Hepatitis C Patients Accepted as Late-Breaking Presentation at the Annual Meeting of the

    Simeprevir Data from COSMOS Study in Hepatitis C Patients Accepted as
 Late-Breaking Presentation at the Annual Meeting of the American Association
                   for the Study of Liver Diseases (AASLD)

PR Newswire

CORK, Ireland, Oct. 7, 2013

CORK, Ireland, Oct. 7, 2013 /PRNewswire/ --Data from the Phase 2a COSMOS
study (Combination Of SiMeprevir and sOfosbuvir in HCV genotype 1 infected
patientS) of the investigational protease inhibitor simeprevir (TMC435)
administered once daily with Gilead Sciences Inc.'s investigational nucleotide
inhibitor sofosbuvir (GS-7977), with and without ribavirin, in genotype 1
chronic hepatitis C adult patients with compensated liver disease has been
accepted as a late-breaking oral presentation at the upcoming Annual Meeting
of the American Association for the Study of Liver Diseases (AASLD). AASLD
will take place November 1 to 5 in Washington, D.C.

The COSMOS data will be presented during the late-breaking oral session on
Monday, November 4, 2:45-4:30 p.m. (EST) in Hall E:

  oSVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir
    (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV
    genotype 1 treatment-naive and prior null responder patients: The COSMOS

       oLead Author: Ira M. Jacobson, Weill Cornell Medical College, New
         York, USA

Additional simeprevir data are scheduled for presentation at the 2013 AASLD
Annual Meeting on Sunday, November 3 and were announced on October 1. Full
session details and data presentation listings for the 2013 AASLD Annual
Meeting can be found at

About Simeprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed
by Janssen R&D Ireland and Medivir AB for the treatment of genotype 1 and
genotype 4 chronic hepatitis C in adult patients with compensated liver
disease, including all stages of liver fibrosis. Simeprevir works by blocking
the protease enzyme that enables the hepatitis C virus to replicate in host

Simeprevir was approved in Japan in September 2013 for the treatment of
genotype 1 hepatitis C. In the U.S., the New Drug Application (NDA) filed by
Janssen for simeprevir administered once daily in combination with pegylated
interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C
in adult patients was granted Priority Review designation by the Food and Drug
Administration (FDA) in May. A Marketing Authorisation Application was
submitted to the European Medicines Agency (EMA) in April seeking approval of
simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C.
To date, more than 3,700 patients have been treated with simeprevir in
clinical trials.

Janssen is responsible for the global clinical development of simeprevir and
has acquired exclusive, worldwide marketing rights, except for in the Nordic
countries. Medivir will retain marketing rights for simeprevir in these

For additional information about simeprevir, please

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause
of chronic liver disease, is the focus of a rapidly evolving treatment
landscape. Approximately 150 million people are infected with hepatitis C
worldwide – including approximately 3.2 million people in the United States –
and 350,000 people per year die from the disease globally. When left
untreated, hepatitis C can cause significant damage to the liver including
cirrhosis. Additionally, hepatitis C may increase the risk of developing
complications from cirrhosis, which may include liver failure.

About Janssen R&D Ireland
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Driven by our commitment to patients, we develop
innovative products, services and healthcare solutions to help people
throughout the world. Janssen R&D Ireland is part of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Please visit for more information.

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. The reader is cautioned not
to rely on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Janssen R&D Ireland,
any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to, general industry
conditions and competition; economic factors, such as interest rate and
currency exchange rate fluctuations; technological advances, new products and
patents attained by competitors; challenges inherent in new product
development, including obtaining regulatory approvals; challenges to patents;
impact of business combinations; changes in behavior and spending patterns or
financial distress of purchasers of health care products and services; changes
to governmental laws and regulations and domestic and foreign health care
reforms; trends toward health care cost containment; and increased scrutiny of
the health care industry by government agencies. A further list and
description of these risks, uncertainties and other factors can be found in
Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal
year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent
filings, are available online at, on request from
Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson &
Johnson undertake to update any forward-looking statements as a result of new
information or future events or developments.)

Media Contact: Daniel De Schryver
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Media Contact: Craig Stoltz
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SOURCE Janssen R&D Ireland

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